Schreiner MediPharm, a leading developer and manufacturer of innovative functional labels for the healthcare industry, has developed a transparent deep-freeze seal that reliably adheres even under deep-freeze conditions while enabling irreversible first-opening indication. As a result, packaged drugs that need to be stored and transported at extreme sub-zero temperatures can be provided with reliable tamper evidence.
Ever since the enactment of the EU Falsified Medicines Directive and ISO 21976, tamper-evident packaging for prescription drugs has been mandatory. Innovative medications such as mRNA substances, biologics, as well as cell and gene therapies are frequently processed, stored, and transported at extreme sub-zero temperatures. Security seals on folding boxes often reach their limits in such temperature ranges. When drugs are processed, stored, or transported at temperatures far below the freezing point, adhesion of conventional seals may be impaired. However, to ensure product integrity and patient safety, reliable tamper evidence is essential.
The new transparent deep-freeze seal from Schreiner MediPharm has been designed specifically for these requirements and is suitable for storage temperatures of down to -196 °C. It features a multi-tear effect as a double security mechanism: An attempt to remove the seal results in the film irreversibly tearing due to the integrated security cuts and—depending on the cardboard surface—to fibers tearing on top of the folding box, making a tampering attempt and first opening immediately visible. An integrated sophisticated guilloche serves as an additional authentication feature and further overt, semi-covert, or covert security features can be added according to the threat scenario.
The deep-freeze seal is available in two variants: One version is designed for dispensing at 10 °C and another one for application down to -50 °C. Both variants meet the requirements of the EU Falsified Medicines Directive and ISO 21976 “Packaging – Tamper Verification Features for Medicinal Product Packaging.” They reliably adhere to folding boxes and secure product integrity across the entire supply chain. Schreiner MediPharm supports pharmaceutical manufacturers with comprehensive consulting along the whole process chain and tailors each solution individually to the specific use case and threat scenario.